Using electrical stimulation to improve balance after stroke
Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
This study is testing if using electrical stimulation along with balance training can help people who have had a stroke improve their balance and reduce their risk of falling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06987682 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to explore the feasibility of combining functional electrical stimulation with balance training to enhance postural control in individuals who have experienced a stroke. Participants will be recruited to assess their willingness to engage in the study procedures and to evaluate the potential effectiveness of this combined approach. The study focuses on individuals who are at risk of falling due to impaired balance following a stroke, particularly those who are more than one year post-event. By testing this intervention, the researchers hope to lay the groundwork for a larger, more definitive study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a middle cerebral artery stroke more than one year ago and can stand independently.
Not a fit: Patients with conditions affecting postural control other than stroke or those with contraindications for electrical stimulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of falls and improve mobility for stroke survivors.
How similar studies have performed: While this approach is innovative, similar studies exploring electrical stimulation for rehabilitation have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or greater * Diagnosed with a middle cerebral artery stroke \>1 year ago * Community-dwelling (i.e. not living in long-term care or other inpatient setting) * Able to stand independently for 60 seconds * Able to understand spoken English Exclusion Criteria: * Any condition other than stroke that significantly affects their postural control (e.g. vestibular disorder, vision loss) * A prior lower extremity fragility fracture * A planned injection of botulinum toxin to the legs during the intervention period * Peripheral nerve damage in the legs * Contraindications for electrical stimulation (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis) * Contraindications for TMS (i.e. seizures, metal in the head) * Previous participation in tSCS within the past 2 years (May affect blinding integrity. Likely uncommon; FES is rarely used in Canada post-stroke.)
Where this trial is running
Toronto, Ontario
- KITE Research Institute, Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Kristin E Musselman, PhD
- Email: kristin.musselman@uhn.ca
- Phone: 416-597-3422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.